1,083
Participants
Start Date
October 15, 2025
Primary Completion Date
June 1, 2030
Study Completion Date
December 31, 2030
Mitomycin (MM)
Mitomycin 30mg/m2/4 litres of perfusion liquid (dextrose 1.5%). Single intraoperative dose.
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
FOLFOX6 consists in oxaliplatin 85 mg/m2 iv. on day 1, 5FU 400 mg/m2 iv. in bolus followed by 2400 mg/m2 in a continuous infusion for 46 hours. Leucovorin: 400mg/m2 folinic acid (racemid dl) in a continuous infusion for 2 hours. Repeat every 2 weeks. Haematological recovery to ANC \>1.5x109/L and platelets \>75x109/L should be ensured prior to Day 1 of each 14-day cycle.
Cytoreductive surgery
Cytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women
Hospital Universitario Reina Sofia, Córdoba
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
OTHER
Spanish Association of Surgeons (AEC)
OTHER
Sociedad Española de Oncología Quirúrgica
OTHER
Maimónides Biomedical Research Institute of Córdoba
OTHER